As of June 10, 1997, FDA no longer provides IND, NDA, ANDA or Drug Master Files application binders to outside firms - Firms are required to have their own binders made and printed according to the following specifications - If you have any questions or need additional information, please contact Mia Prather at 301-796-0618.

POLYETHYLENE BINDERS-

Must be high impact linear plastic (matte finish or similar) - Must be able to withstand temperatures up to 150 degrees - Material should have a surface smooth enough to allow printing with a complete bonding of ink to the surface after a minimum of one hour drying time - Should be free from streaks, blisters, scratches and mottling -

PRINTING - Required on front folder in a clear, sharp, permanent-type print in BLACK ink - Permanent adhesive labels may be used in a clear, sharp print - Printing must withstand a "Scotch Tape Test" which consists of pressing a strip of "Scotch" tape firmly on the printed area and removing - There should be NO transfer of the printed area on the tape -

BINDING - POLYETHYLENE binders (front and back) MUST contain an internal (HIDDEN) hinge formed in the material by heat and pressure - Hinge should extend along the entire left-hand binding edge of the binder and be of a depth to provide a clean straight fold free from wrinkle when created or folded on the hinge - Hinge holes should be reinforced with metal eyelets and suitable for accommodating an ACCO-type fastener allowing for expansion - Outside binder surfaces MUST be smooth with NO exposed hinges or fastener -

PAPER binders (front and back) MUST have 2 hinge holes scored along the entire left-hand binding edge and must be of a depth to provide a clean straight fold free from wrinkle when creased or folded on the score - Hinge holes should be reinforced and suitable for accommodating an ACCO-type fastener allowing for expansion -

Round corner the inside edge of tab on back folder and outside edges of the front and back folders on polyethylene and paper binders -